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New Delhi: The Delhi high court on Tuesday stayed a government order that banned drugs made by Abbott India and Macleods Pharma.

The drugs were banned last week after an expert committee found that they posed health risks. Today’s decision by the Delhi high court comes a day after Pfizer India got a relief on the ban of its cough syrup Corex.

Meanwhile, Procter and Gamble Hygiene and Health Care, too, approached the high court on Tuesday for a stay on the ban of its popular drug for cold and cough, Vicks Action 500 Extra.

The full impact on the ban on 344 drug combinations on the Indian pharmaceutical industry would extend to be about 3,800 crore annually, according to the industry estimates.

“This is going to affect major companies like Abbott and Pfizer the most," said Hari Natarajan, vice-president, business intelligence, India and global audit of AIOCD AWACS, a market researcher.

According to the latest data released by AIOCD AWACS, Abbott Healthcare is likely to suffer a loss of 485 crore, followed by MacLeods Pharma of around 370 crore and Pfizer to the tune of 368 crore.

Sanjay Jain, additional solicitor general, who appeared for the government, said, “It must be seen that the notification has not been issued keeping a specific company in mind. The expert committee, based on whose recommendation it was passed, is empowered by Parliament to restrict the sale of drugs which contain ingredients in such quantity that they may not have a therapeutic value."

He also added that public interest would not be hampered if the sale of a fixed combination drugs was stopped.

Granting a temporary stay on the ban, Justice Rajiv Sahai Endlaw said, “I do not see a reason why interim relief should not be granted to the pharmaceutical companies. What has suddenly gone wrong with FDCs (fixed dose combinations) that have been in the market since the last 20 years?"

When contacted an Abbott spokesperson said, “Abbott reviewed the DCGI (Drug Controller General of India) notification regarding FDCs and approached the Delhi high court for relief as we were not informed, consulted or allowed a representation by the authority for some important products. Abbott has received an interim injunction suspending the operation of the said notification which prohibits the manufacture, sale and distribution of several FDCs that have already been approved for use, till the next date of hearing."

The company’s Phensedyl cough syrup had received DCGI approval in 1995 and is in the Indian market since the 1980s.

“Some of the other formulations in our petition are in use globally, including the US, UK and Australia, and are approved by regulatory bodies such as the US FDA (Food and Drug Administration) and have been the treatment of choice in specific medical conditions," the Abbott spokesperson added.

Procter and Gamble Hygiene and Health Care Ltd, the Indian unit of the world’s largest consumer goods company, had earlier on Tuesday said that it was considering challenging the government order.

“We are aware of the recent notification issued by the central government (health ministry) in relation to fixed dose combination drugs, which impacts a large number of products in the market. Accordingly, we have stopped manufacturing and distributing Vicks Action 500 Extra."

The Organization of Pharmaceutical Producers of India (OPPI), a lobby of multinational pharmaceutical companies in India, said the sudden notification may deny patients access to some medicines that are approved as safe and efficacious in India and globally.

The Indian Drugs Manufacturers Association (IDMA) said it was “shocked" to find that FDCs which had been approved by DCGI office itself were banned, while the Indian Parmaceutical Alliance (IPA) said such a measure should be implemented gradually.

Patient advocacy groups and doctor bodies welcomed the ban. “The FDC issue has been harming the country since more than 30 years," said Dr Mira Shiva, a member of the Central Council for Health, a Delhi-based patient advocacy group.

When two or more drugs are combined, the risk should be assessed not just in the drug reaction but also in the drug-to-drug interaction, Shiva said.

“The government has been somewhat proactive and now, new products have to go through three different committees before approval," said S. Srinivasan of the All India Drug Action Network, a public health body that has been taking legal recourse to address issues related to FDCs.

“On our part, we have already listed out around 102 irrational combinations which should not be prescribed," said Marthanda Pillai, president of the Indian Medical Association, an association of medical doctors.

Shares of Procter and Gamble fell 1% on Tuesday, while those of Pfizer fell 3.15% and those of Abbott India gained 0.26% on BSE.

Viswanath Pilla and Trushna Udgirkar in Hyderabad and Sapna Agarwal in Mumbai contributed to this story.

shine.j@livemint.com

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